FDA 510(k) Decisions During July, 1976  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K760207 07/26/1976 KIT, FOLATE RADIOASSAY SC.7 AMERSHAM CORP.
K760124 07/20/1976 AUTO CELL DILUENT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760123 07/20/1976 AUTOZYME BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760041 07/16/1976 FILTER, RESPIRATORY (U-MID) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760045 07/20/1976 KIT, RADIOASSAY, SERUM IRON BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760044 07/26/1976 KIT, RIA, HUMAN THYROID HORMONE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760039 07/16/1976 VALVE, I.M.V. (U-MID ONE WAY) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760073 07/20/1976 BASIN, WASH, 6-QT RECTANGULAR BEMIS HEALTH CARE
K760072 07/20/1976 CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR BEMIS HEALTH CARE
K760071 07/20/1976 TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 BEMIS HEALTH CARE
K760070 07/20/1976 TUMBLER, PERSONAL, ROUND, 9 OUNCE BEMIS HEALTH CARE
K760134 07/20/1976 PROCEDURE, RA, THYROXINE BINDING PROTEIN BIO-RAD
K760133 07/20/1976 PROCEDURE, RED CELL FOLATE ASSAY BIO-RAD
K760135 07/20/1976 TEST, RA, QUANTA-COUNT T-4 BIO-RAD
K760132 07/20/1976 TEST, RIA, TSH QUANTIMUNE BIO-RAD
K760095 07/20/1976 RESPIRIZOR CAMPILLARY SYSTEMS
K760159 07/20/1976 AGGREGOMETER, DUAL CHANNEL PLATELET CHRONO-LOG CORP.
K760198 07/19/1976 KIT, PLATELET AGGREGATION REAGENT (#390) CHRONO-LOG CORP.
K760226 07/21/1976 PASTE, ACCOE IMPRESSION COE LABORATORIES, INC.
K760225 07/21/1976 PUTTY, ACCOE COE LABORATORIES, INC.
K760138 07/19/1976 BANDAGE, CEB COTTON ELASTIC CONCO MEDICAL CO.
K760141 07/19/1976 BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC CONCO MEDICAL CO.
K760139 07/19/1976 BANDAGE, E-COTTON ELASTIC CONCO MEDICAL CO.
K760142 07/19/1976 BANDAGE, RAPIDO-LASTIC COTTON/NYLON CONCO MEDICAL CO.
K760140 07/19/1976 BANDAGE, WRINKY-LASTIC ELASTIC GAUZE CONCO MEDICAL CO.
K760085 07/20/1976 BASIN, STERILE (#3200) CONCORD LABORATORIES, INC.
K760086 07/16/1976 TRAY, BLOOD SAMPLING (PULSATOR II) CONCORD LABORATORIES, INC.
K760013 07/20/1976 PACER SYSTEMS ANALYZER (CORDIS) CORDIS CORP.
K760197 07/19/1976 ACCUVETTE II COULTER ELECTRONICS, INC.
K760231 07/21/1976 IMPRESSION MATERIAL, DENTAL SILICON RTV CROWN DELTA CORP.
K760236 07/26/1976 BUR, SURGICAL CARBIDE CUTTER LABORATORIES, INC.
K760235 07/26/1976 SUTURE GUIDE CUTTER LABORATORIES, INC.
K760200 07/20/1976 PROSTHESIS, PATELLAR ARTICULAR SURFACE DEPUY, INC.
K760258 07/26/1976 BITE STICK, DYNA DYNA-MED
K760192 07/19/1976 COMPUTER, THERMODILUTION CARDIAC (9520) EDWARDS LABORATORIES
K760152 07/19/1976 FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) EDWARDS LABORATORIES
K760157 07/19/1976 SPHYGMOMANOMETER EYVIRCO
K760166 07/20/1976 STIMULATOR, SONIC CONTROL (AS-1) FARRALL INSTRUMENTS, INC.
K760076 07/16/1976 ABSORBER, ANESTHESIA CIRCLE SYS, CO2 FRASER SWEATMAN, INC.
K760170 07/19/1976 INTRAUTERINE SOUND, PLASTIC DISPOSABLE G.D. SEARLE AND CO.
K760027 07/20/1976 DSP - STAIN PACK HARLECO
K760031 07/20/1976 HISTOCHEMICAL PAS REACTION SET HARLECO
K760129 07/20/1976 SALINE, ISOTONIC BUFFERED, AZIDE-FREE HARLECO
K760169 07/20/1976 DIFFUSION SYSTEM, SINGLE-BREATH (47404A) HEWLETT-PACKARD CO.
K760150 07/19/1976 MONITOR, PATIENT (MODEL 78331A) HEWLETT-PACKARD CO.
K760160 07/19/1976 MONITOR, PATIENT (MODEL 78333A) HEWLETT-PACKARD CO.
K760089 07/20/1976 TEST, IN-VITRO DIAGNOSTIC HOFFMANN-LA ROCHE, INC.
K760082 07/16/1976 BOTTLE, CONDENSATE (#1628) INSPIRON CORP.
K760080 07/15/1976 CANNULA, NASAL, FOR OXYGEN INSPIRON CORP.
K760081 07/15/1976 FILTER, BACTERIA (#2290) INSPIRON CORP.
K760037 07/16/1976 HEATER, IMMERSION W/ HUMIDIFIER & NEBUL. INSPIRON CORP.
K760064 07/21/1976 CATHETER, THERMAL DILUTION, ANIMAL & PED INSTRUMENTATION LABORATORY CO.
K760067 07/21/1976 CATHETER, THERMAL DILUTION, OPEN CHEST INSTRUMENTATION LABORATORY CO.
K760065 07/21/1976 CATHETER, THERMAL DILUTION, PEDIATRIC INSTRUMENTATION LABORATORY CO.
K760208 07/26/1976 OXIMETER, CO-, IL MODEL 282 INSTRUMENTATION LABORATORY CO.
K760119 07/20/1976 SAMPLER, FLAMELESS (IL MODEL 555) INSTRUMENTATION LABORATORY CO.
K760066 07/21/1976 TRAY, ICED INJECTABLE (26420) INSTRUMENTATION LABORATORY CO.
K760202 07/19/1976 TUBE, STERILE CONDUCTIVE CONNECTING IPCO CORP.
K760203 07/19/1976 TUBE, STERILE NON-CONDUCTIVE CONNECTING IPCO CORP.
K760075 07/20/1976 KIT, METHADONE (TOXI-PAK IMMUNO HI) J.T. BAKER CHEMICAL CO.
K760074 07/20/1976 KIT, MORPHINE (TOXI-PAK IMMUNO HI) J.T. BAKER CHEMICAL CO.
K760103 07/16/1976 CAP, INJECTION (#4600) JELCO LABORATORIES
K760110 07/16/1976 FILTER, I.V. (#4700) JELCO LABORATORIES
K760111 07/16/1976 FILTER, I.V., WITH FLASH BULB (#4701) JELCO LABORATORIES
K760019 07/20/1976 VACUUM TUBES, PEDIATRIC SIZES (J-VAC) JELCO LABORATORIES
K760018 07/20/1976 VACUUM TUBES, STERILE (J-VAC) JELCO LABORATORIES
K760250 07/26/1976 BANDAGE, TRIANGULAR NO. 8068 JOHNSON & JOHNSON PROFESSIONALS, INC.
K760118 07/20/1976 THERMOMETER, DIGITAL FEVER (MEDITEMP) JOHNSON & JOHNSON PROFESSIONALS, INC.
K760227 07/26/1976 RADIOIMMUNOASSAY KALLESTAD LABORATORIES, INC.
K760094 07/16/1976 SPONGE, CURITY WASHED GAUZE KENDALL RESEARCH CENTER
K760121 07/16/1976 IMPULSE HEAT SEALER LORVIC CORP.
K760052 07/16/1976 KIT, PREP SHAVE M-C IND., INC.
K760017 07/20/1976 CONSIOUS SEDATION (ANALOR P-76) MCKESSON CORP.
K760090 07/20/1976 GRAFT, COOLEY GUIDELINE, STERILE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760092 07/20/1976 GRAFT, COOLEY WOVEN VASCULAR, STERILE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760091 07/20/1976 GRAFT, MICROVEL GUIDELINE, STERILE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760087 07/20/1976 TAPE, VASCULAR, 1/4" DACRON MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760006 07/20/1976 RADIOASSAY, CONCEPT 4 MICROMEDIC SYSTEMS
K760084 07/26/1976 MONITOR, GSR (NB-401) NARCO BIO-SYSTEMS
K760083 07/20/1976 PHYSIOSCOPE NARCO BIO-SYSTEMS
K760068 07/20/1976 KIT, RIA, GENTAMICIN SULF. NEW ENGLAND NUCLEAR
K760102 07/16/1976 FLOWMETER, P.C., REDESIGNED VERSION OHIO MEDICAL PRODUCTS
K760101 07/15/1976 OXYGEN & RESUSCITATION (HOPE II MODEL) OHIO MEDICAL PRODUCTS
K760149 07/19/1976 CONDUCTIVE ANESTHSIA BREATH. CIRCUIT OMNICON MEDICAL CORP.
K760239 07/26/1976 CEMENT, ULTRA-BOND ORATEC DENTAL PRODUCTS
K760238 07/26/1976 IMPRESSION MATERIAL, TRIFLEX SILICONE ORATEC DENTAL PRODUCTS
K760240 07/26/1976 IMPRESSION MATERIAL, TRIFLEX SILICONE ORATEC DENTAL PRODUCTS
K760106 07/20/1976 PROSTHESIS, TOTAL HIP-FEMORAL ORTHOPEDIC EQUIPMENT CO., INC.
K760109 07/20/1976 PROSTHESIS, TOTAL HIP-RASP ORTHOPEDIC EQUIPMENT CO., INC.
K760108 07/20/1976 PROSTHESIS, TOTAL HIP-TEST CUP ORTHOPEDIC EQUIPMENT CO., INC.
K760107 07/20/1976 PROSTHESIS, TOTAL HIP-TEST FEMORAL ORTHOPEDIC EQUIPMENT CO., INC.
K760078 07/20/1976 REAGENT, RIA TRIIODOTHYRONINE T3 (#200) OXFORD LABORATORIES, INC.
K760079 07/20/1976 REAGENT, THYROXINE T4 (#210) OXFORD LABORATORIES, INC.
K760143 07/20/1976 SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN OXFORD LABORATORIES, INC.
K760148 07/20/1976 SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN OXFORD LABORATORIES, INC.
K760144 07/20/1976 SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760146 07/20/1976 SERUM, IGA GOAT ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760145 07/19/1976 SERUM, IGG GOAT ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760147 07/20/1976 SERUM, IGM ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760113 07/15/1976 SPONGE, LAPAROTOMY GAUZE PARKE-DAVIS CO.
K760016 07/16/1976 SURGICAL BLADES (BEAVER) PARKE-DAVIS CO.
K760164 07/20/1976 UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) PARKE-DAVIS CO.
K760171 07/19/1976 FIBERBRONCHOSCOPE (PENTAX FB-17A) PILLING CO.
K760161 07/20/1976 TEST, ACID PHOSPHATASE PRINCETON BIOMEDIX
K760245 07/26/1976 PROSTHESIS, RICHARDS MOD II KNEE RICHARD'S MEDICAL EQUIP., INC.
K760125 07/19/1976 AIRWAY, ARGYLE NASOPHARYNGEAL SHERWOOD MEDICAL INDUSTRIES
K760163 07/20/1976 CATHETER, INTRAVASCULAR (MEDICUT T) SHERWOOD MEDICAL INDUSTRIES
K760136 07/20/1976 CATHETER, THORACIC DRAIN SHERWOOD MEDICAL INDUSTRIES
K760137 07/16/1976 TUBE, FEEDING, ARGYLE SHERWOOD MEDICAL INDUSTRIES
K760131 07/20/1976 AGARO-GEL, PRODUCT # A1266 SIGMA CHEMICAL CO.
K760077 07/16/1976 TEST, RIA, SERUM DIGOXIN SMITH KLINE DIAGNOSTICS, INC.
K760120 07/20/1976 PULSE CARDULE (MODEL 1859/1860 ECG) SPACELABS, INC.
K760009 07/20/1976 COLORIMETRIC DETERMINATION (LDH) THE DOW CHEMICAL CO.
K760010 07/26/1976 COLORIMETRIC DETERMINATION (SGOT/SGPT) THE DOW CHEMICAL CO.
K760011 07/26/1976 REAGENT, TRIGLYCERIDES THE DOW CHEMICAL CO.
K760112 07/16/1976 SPECTROPHOTOMETER (JUNIOR III) THE PERKIN-ELMER CORP.
K760012 07/16/1976 BLOOD WARMER (CODE 4R4305) TRAVENOL LABORATORIES, S.A.
K760126 07/20/1976 LENS, HARD CONTACT TRU-FORM OPTICS, INC.
K760130 07/20/1976 PROSTHESIS, VASCULAR BIFURCATED USCI, DIV. C.R. BARD, INC.
K760215 07/21/1976 HEARING AID, S-522 FM VICON INSTRUMENT CO.
K760122 07/16/1976 WILL-CERAM Y-2 WILLIAMS GOLD REFINING CO., INC.
K760205 07/26/1976 RADIOGRAPHIC UNIT, XRC-1 XRC, INC.
K760209 07/26/1976 ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP ZEUS SCIENTIFIC, INC.
K760153 07/20/1976 TEST, (IVDP) ANTINUCLEAR ANTIBODY ZEUS SCIENTIFIC, INC.
K760155 07/20/1976 TEST, (IVDP) MITOCHONDRIAL ANTIBODY ZEUS SCIENTIFIC, INC.
K760156 07/20/1976 TEST, (IVDP) SMOOTHMUSCLE ANTIBODY ZEUS SCIENTIFIC, INC.
K760154 07/20/1976 TEST, (IVDP) THYROID ANTIBODY ZEUS SCIENTIFIC, INC.
K760001 07/26/1976 ARCH SUPPORT (ARCH AID) ZIMMER, INC.
K760003 07/26/1976 CAST MATERIAL (WICKET STOCKINETTE) ZIMMER, INC.
K760002 07/26/1976 KNEE AID ZIMMER, INC.


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